FDA.reportPublic FDA data

Healing Cap

Primary DI
00810008462812
Brand
Healing Cap
Company
Little Implant Co.
Model
PHC487
Device description
Healing Cap Standard - Length: 7 Diameter: 4.8
Published
2019-05-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810008462812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008462812008100084628128100084628120810008462812

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
050003777
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810008462584AbutmentPPTA012019-05-13
00810008462591AbutmentPPTA022019-05-13
00810008462607AbutmentPPTA032019-05-13
00810008462621Cover ScrewRR00SC2019-05-13
00810008462638Healing CapRRHA012019-05-13
00810008462645Healing CapRRHA032019-05-13
00810008462669AbutmentRRNRTA2019-05-13
00810008462690Healing CapPHC3822019-05-13
00810008462706Healing CapPHC3832019-05-13
00810008462713Healing CapPHC3842019-05-13
00810008462720Healing CapPHC3852019-05-13
00810008462737Healing CapPHC3862019-05-13
00810008462744Healing CapPHC3872019-05-13
00810008462751Healing CapPHC4812019-05-13
00810008462768Healing CapPHC4822019-05-13
00810008462775Healing CapPHC4832019-05-13
00810008462782Healing CapPHC4842019-05-13
00810008462799Healing CapPHC4852019-05-13
00810008462805Healing CapPHC4862019-05-13
00810008462829Healing CapPHC5522019-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
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